Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF CILNIDIPINE AND OLMESARTAN MEDOXOMIL IN COMBINED TABLET DOSAGE FORM.

Manzoor Ahmed, Rashmi D.R*, Satishkumar Shetty A, Anil Kumar S.M, Ravi M.C, Kuppast I.J

ABSTRACT

The objective of the current study was to develop a simple, accurate, precise and rapid RP-HPLC method with subsequently validate as per ICH guidelines for the determination of Cilnidipine (CIL) and Olmesartan medoxomil (OLM) using mobile phase [mixture of acetonitrile and methanol in the ratio of 60:40] as the solvent. The proposed method involves the measurement of Retention time at selected analytical wavelength. 260.0 nm was selected as the analytical wavelength. The retention time of CIL and OLM was found to be 3.351 and 1.833 respectively. The linearity of the proposed method was investigated in the range of 5-25 μg/ml (r2 = 0.9999) for CIL and 10-50 μg/ml (r2 = 0.9998) for OLM respectively. The method was statistically validated for its linearity, accuracy and precision. Both inter-day and intra-day variation was found to be showing less % RSD (Relative Standard Deviation) value indicating high grade of precision of the method.

Keywords: RP-HPLC method, Cilnidipine, Olmesartan medoxomil, Validation.